Salt sensitivity test using N-of-1 trials in people with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will first screen participants with a 2-week high- and low-sodium diet to classify them as salt-sensitive or salt-resistant based on changes in mean arterial pressure. Eligible participants then undergo a 6-week N-of-1 trial consisting of three two-week cycles of alternating high- and low-sodium diets to observe each person's blood pressure response and other metrics. The study aims to see if salt sensitivity is a real trait in individuals with hypertension and to explore potential impacts on pulse, sleep, mood, and metabolic differences. Safety and adherence are monitored throughout, with inclusion and exclusion criteria designed to select adults with mild-to-moderate blood pressure and no conflicting medical conditions or dietary restrictions. Overall, the trial uses personalized, repeated dietary interventions to characterize individual responses to salt intake.

Why it matters

Who can join: the full rules

Phase 1: Salt Sensitivity Screening

Inclusion:

1. Signed informed consent for the salt sensitivity test.
2. Systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg.
3. Not taking any antihypertensive medication, or have had a stable antihypertensive regimen for the past three months and agree not to adjust their medication during the study period.
4. Able to comply with consuming the study-provided diet throughout the study period.

Exclusion:

1. Special dietary requirements, such as allergies to common foods (e.g., eggs, seafood, peanuts), or conditions like asthma, irritable bowel syndrome, lactose intolerance, chronic kidney disease stage 4 or higher, history of gastrointestinal surgery, or special dietary needs due to other illnesses, surgery, or weight loss.
2. Diagnosed with chronic diseases: any malignancy with a life expectancy of less than one year; chronic heart failure, severe depression or other mental disorders, long-term bedridden status, or mobility limitations.
3. Experienced acute myocardial infarction or stroke within the past 6 months.
4. Acute illnesses such as upper respiratory tract infection, fever, or severe diarrhea that have not yet resolved.
5. Alcohol abuse.
6. Pregnant or breastfeeding women, or women planning to become pregnant.
7. Individuals who are deaf, mute, or have cognitive impairments that hinder communication.

Phase 2: N-of-1 Trial

Inclusion:

1. Classified as salt-sensitive or salt-resistant through the Phase 1 screening:
2. Salt-Sensitive (SS) Group: Participants with a change in mean arterial pressure (ΔMAP) ≥ 5 mmHg and in the upper 1/6 of the distribution of ΔMAP from the salt sensitivity test.
3. Salt-Resistant (SR) Group: Participants with a change in mean arterial pressure (ΔMAP) \< 5 mmHg and in the lower 1/6 of the distribution of ΔMAP from the salt sensitivity test.
4. Signed informed consent for the n-of-1 trial.

Exclusion:

1. Failed to complete the salt sensitivity test as required, or consumed less than 80% of the study-provided meals during the salt sensitivity test (i.e., fewer than 34 meals over 14 days).
2. Experienced adverse events during the salt sensitivity test that, in the investigator's judgment, make it inappropriate to continue in the study.

Where it's running

• Peking University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Yifang Yuan — Peking University
• Study coordinator: Yifang Yuan
• Email: yyfjulie@163.com
• Phone: 0086-17310387323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.